NCT00114686

Efficacy and Safety of Quetiapine Fumarate (SEROQUEL®) in the Treatment of Alcohol Dependency in Patients With Bipolar Disorder

A Multicenter, Randomized, Placebo-Controlled, Parallel-Group, Double-Blind, Phase III Study to Compare the Efficacy and Safety of Quetiapine Fumarate (SEROQUEL®) Versus Placebo as Adjunct Therapy With Mood Stabilizers (Lithium or Divalproex) for the Treatment of Alcohol Dependence in Patients With Bipolar I Disorder

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 350 (planned)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 21 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether treatment with Quetiapine Fumarate (SEROQUEL) in conjunction with mood stabilizers (Lithium or Divalproex) for 12 weeks helps patients who have Bipolar I Disorder with Alcohol Dependence

Conditions

• Bipolar I Disorder
• Alcohol Dependence

Interventions

Type	Name	Description
DRUG	Quetiapine fumarate
DRUG	lithium
DRUG	divalproex

Timeline

• Start date: 2006-01-01
• Completion: 2007-04-01
• First posted: 2005-06-17
• Last updated: 2013-01-04

Locations

38 sites across 1 country: United States